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Thromboprophylaxis
Selected AbstractsShould patients be informed about the risk of heparin-induced thrombocytopenia before prolonged low-molecular-weight heparin thromboprophylaxis post-trauma/orthopedic surgery?EUROPEAN JOURNAL OF HAEMATOLOGY, Issue 3 2007Norbert Lubenow Abstract Objectives:, Heparin-induced thrombocytopenia (HIT) is an immune-mediated prothrombotic adverse drug effect that occurs less frequently with low-molecular-weight heparin (LMWH) than with unfractionated heparin (UFH) in post-trauma/orthopedic surgery patients. The life-threatening nature of HIT raises the question whether informed consent for this treatment-induced adverse effect should be obtained, particularly as LMWH is often continued during the outpatient period when clinical and platelet count monitoring become problematic. Paradoxically, refusal of thromboprophylaxis as a result of seeking informed consent could increase risk for thrombosis. Methods:, We evaluated in patients undergoing routine LMWH thromboprophylaxis post-trauma/orthopedic surgery the feasibility of obtaining informed consent, using a standardized questionnaire to determine patient preferences. We also identified the proportion of HIT patients in our laboratory comprised of trauma/orthopedic surgery patients from 1995,1997 and 2002,2004 (time periods characterized, respectively, by UFH and LMWH thromboprophylaxis for this patient population). Results:, None of 460 patients in whom informed consent was administered rejected LMWH thromboprophylaxis. The patients' perception of the informed consent process and the written information provided about the risk of HIT and its risk due to clinical consequences were highly favorable. From 1995,1997 to 2002,2004, the proportion of HIT identified among trauma/orthopedic surgery patients declined from 30.3% to 1.2% (P < 0.0001). Conclusions:, Obtaining informed consent about HIT is feasible in written form and does not cause refusal of LMWH thromboprophylaxis. Despite the uncommon occurrence of HIT during LMWH thromboprophylaxis, informed consent increases patient's awareness of this potentially life-threatening adverse drug effect, an outcome that could increase outpatient recognition of the diagnosis. [source] Fatal postoperative pulmonary embolism in mild haemophiliaHAEMOPHILIA, Issue 2 2006J. H. BUTCHER Summary., The use of thromboprophylaxis in patients with haemophilia receiving factor replacement is often not considered necessary, but remains an area of debate. In this report we describe a patient with mild haemophilia A, who underwent major pelvic surgery. He had several underlying risk factors associated with the development of thromboembolism, and ultimately died as a direct consequence of multiple pulmonary emboli. The need for thromboprophylaxis and the risk balance ratio should always be considered in patients with bleeding disorders if they fall into what would otherwise be high-risk category for hospital acquired venous thromboembolism. [source] Haemophilia and thrombophilia: an unexpected association!HAEMOPHILIA, Issue 4 2004Y. Dargaud Summary., In patients with haemophilia, a close correlation is usually observed between the clinical expression of the disease and plasmatic factor VIII/factor IX clotting activity. However, some patients experience milder bleeding phenotypes than others, although they exhibit a similar biological profile. The high prevalence of some inherited thrombophilia risk factors offers the possibility of a co-inheritance in haemophilic patients which could influence the phenotypic expression of the disease. Rare thrombotic complications occurring in haemophiliacs could also be facilitated by the co-inheritance of modifier genes. The majority of thrombotic events occurring in haemophiliacs are in relation to clotting factor infusions or central venous catheters. Concerning surgical situations, in the absence of therapeutic recommendations, postoperative thromboprophylaxis is not systematically performed in haemophiliacs. However, substitutive treatment more or less completely corrects the coagulation defect and makes the venous thrombosis risk closer to the control population. It should be emphasized that haemophilia does not fully protect against venous thromboembolic disease. Patients with haemophilia very infrequently experience thrombotic events. Thus, the management of thrombotic complications occurring in haemophilic patients should be discussed in each case according to the precipitating risk factors, the clinical context and the thrombo-haemorrhagic balance of the patient with respect to a particular clinical situation. [source] Should we give thromboprophylaxis to patients with liver cirrhosis and coagulopathy?HPB, Issue 6 2009Marco Senzolo Abstract Patients with liver cirrhosis are characterized by decreased synthesis of both pro- and anticoagulant factors, and recently there has been evidence of normal generation of thrombin resulting in a near normal haemostatic balance. Although it is generally recognized that bleeding is the most common clinical manifestation as a result of decreased platelet function and number, diminished clotting factors and excessive fibrinolysis, hypercoagulability may play an under recognized but important role in many aspects of chronic liver disease. In fact, they can encounter thrombotic complications such as portal vein thrombosis, occlusion of small intrahepatic vein branches and deep vein thrombosis (DVT). In particular, patients with cirrhosis appear to have a higher incidence of unprovoked DVT and pulmonary embolism (PE) compared with the general population. In dedicated studies, the incidence of DVT/PE ranges from 0.5% to 1.9%, similar to patients without comorbidities, but lower than patients with other chronic diseases (i.e, renal or heart disease). Surprisingly, standard coagulation laboratory parameters are not associated with a risk of developing DVT/PE; however, with multivariate analysis, serum albumin level was independently associated with the occurrence of thrombosis. Moreover, patients with chronic liver disease share the same risk factors as the general population for DVT/PE, and specifically, liver resection can unbalance the haemostatic equilibrium towards a hypercoagulable state. Current guidelines on antithrombotic prophylaxis do not specifically comment on the cirrhotic population as a result of the perceived risk of bleeding complications but the cirrhotic patient should not be considered as an auto-anticoagulated patient. Therefore, thromboprophylaxis should be recommended in patients with liver cirrhosis at least when exposed to high-risk conditions for thrombotic complications. Low molecular weight heparins (LWMHs) seem to be relatively safe in this group of patients; however, when important risk factors for bleeding are present, graduated compression stockings or intermittent pneumatic compression should be considered. [source] Thromboprophylaxis in ENT patients: a national surveyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 10 2006S. O'HANLON Summary The aim of this survey was to establish whether ENT departments in England follow British Medical Journal guidelines on thromboprophylaxis. A telephone survey of doctors in 80 ENT departments was used to present six clinical scenarios. The participants were asked what their local department routinely did. They were also asked whether they were aware of a local or national thromboprophylaxis policy. For patients undergoing procedures other than major head and neck procedures, compliance was poor and ranged between 7.5% and 37.5%. For laryngectomy, the rate was 82.6%. There was no statistical difference in answers given by doctors of different levels of seniority. Where local thromboprophylaxis guidelines exist, compliance is found to be statistically better. These results suggest that most ENT departments do not follow national or local guidelines on thromboprophylaxis. Greater awareness of existing guidelines is required. [source] Venous thromboembolism in the medically ill patient: a call to actionINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 5 2005J.-F. Bergmann Summary The risk of venous thromboembolism (VTE) in medical patients is generally underestimated. However, recent studies including two large double-blind placebo-controlled trials, the Prospective Evaluation of Dalteparin Efficacy for Prevention of VTE in Immobilised Patients trial (PREVENT) and prophylaxis in MEDical patients with ENOXaparin, study show that low-molecular-weight heparins (LMWHs) provide effective thromboprophylaxis for medical patients at risk from VTE without increasing the risk of bleeding. In PREVENT the significant 45%, reduction in VTE among patients receiving dalteparin 5000 IU once daily for 14 days was attributed entirely to a reduction in clinically relevant VTE. The recently published guidelines for the prevention and treatment of VTE, issued by the American College of Chest Physicians, recommend prophylaxis with LMWHs (or low-dose unfractionated heparin) in acutely ill medical patients with risk factors for VTE (grade 1A). Current evidence should encourage the more widespread adoption of thromboprophylaxis in at-risk medical patients, and thus reduce the number of preventable deaths and complications due to VTE. [source] Nordic guidelines for neuraxial blocks in disturbed haemostasis from the Scandinavian Society of Anaesthesiology and Intensive Care MedicineACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 1 2010H. BREIVIK Background: Central neuraxial blocks (CNBs) for surgery and analgesia are an important part of anaesthesia practice in the Nordic countries. More active thromboprophylaxis with potent antihaemostatic drugs has increased the risk of bleeding into the spinal canal. National guidelines for minimizing this risk in patients who benefit from such blocks vary in their recommendations for safe practice. Methods: The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI) appointed a task force of experts to establish a Nordic consensus on recommendations for best clinical practice in providing effective and safe CNBs in patients with an increased risk of bleeding. We performed a literature search and expert evaluation of evidence for (1) the possible benefits of CNBs on the outcome of anaesthesia and surgery, for (2) risks of spinal bleeding from hereditary and acquired bleeding disorders and antihaemostatic drugs used in surgical patients for thromboprophylaxis, for (3) risk evaluation in published case reports, and for (4) recommendations in published national guidelines. Proposals from the taskforce were available for feedback on the SSAI web-page during the summer of 2008. Results: Neuraxial blocks can improve comfort and reduce morbidity (strong evidence) and mortality (moderate evidence) after surgical procedures. Haemostatic disorders, antihaemostatic drugs, anatomical abnormalities of the spine and spinal blood vessels, elderly patients, and renal and hepatic impairment are risk factors for spinal bleeding (strong evidence). Published national guidelines are mainly based on experts' opinions (weak evidence). The task force reached a consensus on Nordic guidelines, mainly based on our experts' opinions, but we acknowledge different practices in heparinization during vascular surgery and peri-operative administration of non-steroidal anti-inflammatory drugs during neuraxial blocks. Conclusions: Experts from the five Nordic countries offer consensus recommendations for safe clinical practice of neuraxial blocks and how to minimize the risks of serious complications from spinal bleeding. A brief version of the recommendations is available on http://www.ssai.info. [source] Thromboprophylaxis for hospitalized medical patients: A Multicenter Qualitative study,,JOURNAL OF HOSPITAL MEDICINE, Issue 5 2009Deborah Cook MD Abstract BACKGROUND: Observational studies have documented that medical patients infrequently receive venous thromboembolism (VTE) prevention. OBJECTIVE: To understand the barriers to, and facilitators of, optimal thromboprophylaxis. PATIENTS: Hospitalized medical patients. DESIGN: We conducted in-depth interviews with 15 nurses, 6 pharmacists, 12 physicians with both clinical and managerial experience, and 3 hospital administrators. SETTING: One university-affiliated and 2 community hospitals. INTERVENTION: Interviews were audiotaped and transcribed verbatim. Transcripts were reviewed and interpreted independently in duplicate. MEASUREMENT: Analysis was conducted using grounded theory. RESULTS: Physicians and pharmacists affirmed that evidence supporting heparin is strong and understood. Clinicians, particularly nurses, reported that mobilization was important, but were uncertain about how much mobilization was enough. Participants believed that depending on individual physicians for VTE prevention is insufficient. The central finding was that multidisciplinary care was also perceived as a barrier to effective VTE prevention because it can lead to unclear accountability by role confusion. Participants believed that a comprehensive, systems approach was necessary. Suggestions included screening and risk-stratifying all patients, preprinted orders at hospital admission that are regularly reevaluated, and audit and feedback programs. Patient or family-mediated reminders, and administrative interventions, such as hiring more physiotherapists and profiling thromboprophylaxis in hospital accreditation, were also endorsed. CONCLUSIONS: Universal consideration of thromboprophylaxis finds common ground in multidisciplinary care. However, results of this qualitative study challenge the conviction that either individual physician efforts or multidisciplinary care are sufficient for optimal prevention. To ensure exemplary medical thromboprophylaxis, clinicians regarded coordinated, systemwide processes, aimed at patients, providers, and administrators as essential. Journal of Hospital Medicine 2009;4:269,275. © 2009 Society of Hospital Medicine. [source] A prospective observational study of a cohort of outpatients with an acute medical event and reduced mobility: incidence of symptomatic thromboembolism and description of thromboprophylaxis practicesJOURNAL OF INTERNAL MEDICINE, Issue 2 2006J.-L. BOSSON Abstract. Objectives., The study was performed to determine the incidence of symptomatic venous thromboembolism in outpatients with an acute medical event causing temporary reduced mobility. Risk factors for venous thromboembolism and thromboprophylaxis practices were also studied. Design., This was a prospective, observational, multicentre, cohort study. Setting., General practitioners randomly selected from a registry of 25 000 active representative doctors in France included eligible outpatients Subjects., Outpatients aged at least 40 years anticipated to have reduced mobility for at least 48 h due to an acute medical event were eligible. Interventions., None required. Main outcome measures., Symptomatic deep-vein thrombosis and pulmonary embolism at 3 weeks were the main study end-points. Results., Overall, 16 532 evaluable patients of mean age 71 years were recruited between October 2002 and June 2003 by 2895 doctors. The main acute medical events leading to reduced mobility were infection, acute rheumatism and falls without fracture. The incidence rates (95% confidence interval) of symptomatic deep-vein thrombosis and pulmonary embolism were 1% (0.84,1.14) and 0.20% (0.13,0.27) respectively. Venous insufficiency in legs, cancer, and a personal or family history of venous thromboembolism were independent risk factors for venous thromboembolism. Pharmacological thromboprophylaxis was initiated in 35.0% (n = 5782) of the patients. The principal driver of prescription was a personal history of venous thromboembolism. Conclusions., The risk of symptomatic venous thromboembolism in outpatients with reduced mobility for medical reasons is close to that reported in medical and surgical inpatients. This risk and the potential need for thromboprophylaxis should be taken into account by primary care doctors. [source] Do anticoagulants improve survival in patients presenting with venous thromboembolism?JOURNAL OF INTERNAL MEDICINE, Issue 6 2003J. Kelly Abstract. Anticoagulants have been available since around 1940 and have become the standard of treatment for venous thromboembolism (VTE) for over four decades. However, as with other treatments which became established before the evidence-based era, there is a paucity of evidence from randomized controlled trials validating their effectiveness in preventing the most feared complication of VTE, recurrent fatal pulmonary embolism (PE). Only two such trials have been performed, the results of which conflict. The bulk of data supporting their use are derived from three sources. First, studies of thromboprophylaxis, and comparisons of shorter and longer courses of anticoagulants in high-risk patients with established VTE have clearly demonstrated their effectiveness in primary and late secondary prevention. Given that heparin has an immediate onset of action, anticoagulants should therefore also be effective in early secondary prevention, the proposed mechanism of action in the acute treatment of VTE. Secondly, studies of inadequately treated patients have consistently shown higher recurrence rates than in those adequately treated. Finally, comparisons of outcomes in untreated and treated historical series, and of untreated historical series to treated series in the modern era have shown substantially lower rates of fatal PE in anticoagulated patients. Because these differences are so marked, harmonize with our current understanding of the mechanism of action of anticoagulants and are supported by other evidence, it is much more likely that they at least partly reflect the effectiveness of anticoagulants as opposed to being explicable purely in terms of accumulated biases and a changing distribution of disease severity. [source] The risk of ipsilateral versus contralateral recurrent deep vein thrombosis in the legJOURNAL OF INTERNAL MEDICINE, Issue 5 2000P. Lindmarker Abstract. Lindmarker P, Schulman S, the DURAC Trial Study Group (Karolinska Hospital, Karolinska Institute, Stockholm, Sweden) The risk of ipsilateral versus contralateral recurrent deep vein thrombosis in the leg. J Intern Med 2000; 247: 601,606. Objectives. To investigate the risk of ipsilateral versus contralateral recurrent deep vein thrombosis in the leg. Design. An open prospective long term follow-up multicentre trial. Patients were followed by frequent outpatient visits at each centre during the first 12 months after inclusion and thereafter annually. Setting. Sixteen hospitals in central Sweden. Subjects. A total of 790 consecutive patients with objectively verified first episode of acute deep vein thrombosis and without diagnosed malignant disease were recruited from a randomized study comparing 6 weeks with 6 months of oral antivitamin K therapy as secondary thromboprophylaxis. Main outcome measures. Deep vein thrombosis in the contralateral leg was confirmed by venography or ultrasound. With regard to the ipsilateral leg, venography was required. Results. A recurrent episode of venous thromboembolism was documented in 192 patients after a mean (±SD) period of 31(±29) months. In 26 additional patients with ipsilateral symptoms the diagnostic critera were not fulfilled. One hundred and eleven patients have deceased and 69 patients withdrew from the study. The 392 patients without recurrent episodes were followed for a median of 96 months with 90% for at least 48 months. An objectively verified recurrent contralateral and ipsilateral deep vein thrombosis occurred in 95 and 54 cases, respectively, and in 41 patients pulmonary embolism was documented. In two patients thromboses with unusual locations were registered. The risk of contralateral versus ipsilateral recurrence was significantly increased with a risk ratio of 1.6 (95% confidence interval 1.4,1.9) in a time to event model. In a multivariate analysis none of the investigated variables were significantly associated with the side of recurrent thrombosis. Conclusions. The risk of a recurrent deep vein thrombosis is increased in the contralateral leg. This brings into question the importance of an impaired venous flow for recurrent episodes of thrombosis. [source] Prolonged activated partial thromboplastin time in thromboprophylaxis with unfractionated heparin in patients undergoing cesarean sectionJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 1 2010Shigeki Matsubara Abstract Aim:, Hemorrhage is an important complication of heparin-thromboprophylaxis after surgery. We attempted to clarify the incidence rate of prolonged activated partial thromboplastin time (APTT), representative of hemorrhagic tendency, in Japanese women who received thromboprophylaxis with unfractionated subcutaneous heparin administration after cesarean section (CS). We also determined factors which affected postoperative APTT. Methods:, We studied 280 women who were administered thromboprophylaxis with unfractionated subcutaneous heparin 5000 IU two times per day after CS. Postoperative APTT under heparin was measured and the incidence of its prolongation was determined. Preoperative APTT, blood loss during surgery, postoperative hematocrit, postoperative serum total protein level, and postpartum body weight were measured, and their correlation with postoperative APTT was determined. Results:, Preoperative and postoperative APTT values were 28.3 (26.7,30.3) and 33.8 (31.0,37.5) seconds for median (interquartile range), respectively. Overall, 7.1% of patients showed ,45 s postoperative APTT. Two patients (0.7%) showed ,60 s APTT, one of whom suffered subcutaneous hemorrhage around the abdominal incision with complete healing. There were no other hemorrhagic complications. Preoperative APTT positively, and postpartum body weight inversely, correlated with postoperative APTT. The amount of blood loss, postoperative hematocrit, and postoperative serum total protein level did not correlate with postoperative APTT. No discernible deep vein thrombosis or pulmonary embolism occurred. Conclusion:, Although 7.1% of women under heparin-thromboprophylaxis showed a prolonged APTT that was 150% of the preoperative APTT, serious side effects were not observed. Subcutaneous administration of unfractionated heparin, if checking APTT prolongation 1 day after surgery, may be safe method of thromboprophylaxis after CS. [source] A randomized, double-blind study of certoparin vs. unfractionated heparin to prevent venous thromboembolic events in acutely ill, non-surgical patients: CERTIFY StudyJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 6 2010H. RIESS Summary.,Background:,In medically ill patients, no contemporary double-blind head-to-head evaluation of low molecular weight heparin vs. unfractionated heparin (UFH) for the prevention of venous thromboembolic events is available. Objectives:,To compare the efficacy and safety of certoparin with those of UFH. Patients/Methods:,In this double-blind, randomized, controlled trial, acutely ill, non-surgical patients aged , 70 years were randomized to certoparin (3000 U of anti-factor Xa once daily) or to UFH (5000 IU t.i.d.). The primary endpoint was the composite of proximal deep vein thrombosis as assessed by bilateral compression ultrasonography, symptomatic non-fatal pulmonary embolism and venous thromboembolism-related death, and was assessed by a blinded central adjudication committee. Non-inferiority margins were set at 1.8 for the odds ratio (OR) and 3.45% for the absolute difference. Results:,Three thousand two hundred and thirty-nine patients aged 78.8 ± 6.3 years were treated for 9.1 ± 3.4 days. The incidence of the primary endpoint was 3.94% in the certoparin group and 4.52% in the UFH group, with a difference in proportions of , 0.59% [95% confidence interval (CI) ,2.09 to 0.92; P < 0.0001 for non-inferiority], and an OR of 0.87 (95% CI 0.60,1.26; P = 0.0001 for non-inferiority). Major bleeding occurred in 0.43% of certoparin-treated patients and 0.62% of UFH-treated patients (OR 0.69; 95% CI 0.26,1.83). Any bleeding occurred at 3.20% in certoparin-treated patients vs. 4.58% in UFH-treated patients (OR 0.69; 95% CI 0.48,0.99; P < 0.05), and 5.73% of certoparin-treated patients and 6.63% of UFH-treated patients experienced serious adverse events. All-cause mortality was 1.27% in certoparin-treated patients and 1.36% in UFH-treated patients. Conclusions:,In acutely ill, non-surgical elderly patients, thromboprophylaxis with certoparin (3000 U of anti-FXa once daily) was non-inferior to 5000 IU of UFH t.i.d., with a favorable safety profile. [source] Incidence and risk factors for pulmonary embolism in the postpartum periodJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 5 2010J. M. MORRIS Summary.,Background: Pregnancy and the postpartum period are times of hypercoagulability, increasing the risk of pulmonary embolism. Better quantification of risk factors can help target women who are most likely to benefit from postpartum thromboprophylaxis with heparin. Objectives: To determine the incidence rate and timing of postpartum pulmonary embolism, and assess perinatal risk factors predictive of the event. Patients/Methods: Antenatal, delivery and postpartum admission records of a cohort of 510 889 pregnancies were analysed. Pulmonary embolism was identified from ICD-10 codes at delivery, transfer or upon readmission at any time in the postpartum period. Results: Pulmonary embolism occurred in 375 women and was most common postpartum. The rate of postpartum pulmonary embolism without an antecedent thrombotic event was 0.45 per 1000 births. By the end of 4 weeks postpartum, the weekly rate approached the background rate of pulmonary embolism in the population. Although the Caesarean section rate rose significantly throughout the study period, and pulmonary embolism was more common following abdominal birth, the rate of pulmonary embolism following Caesarean birth fell. Regression modelling demonstrated that stillbirth (adjusted odds ratio [aOR] =5.97), lupus (aOR = 8.83) and transfusion of a coagulation product (aOR = 8.84) were most strongly associated with pulmonary embolism postpartum. Conclusions: Pulmonary embolism most commonly occurs up to 4 weeks postpartum and following abdominal birth. Despite this the absolute event rate is low and a broadly inclusive risk factor approach to the use of pharmacological thromboprophylaxis will require many women to be exposed to heparin to prevent an embolic event. [source] How can we reduce disagreement among guidelines for venous thromboembolism prevention?JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 4 2010M. SOBIERAJ-TEAGUE See also Struijk-Mulder MC, Ettema HB, Verheyen CC, Büller HR. Comparing consensus guidelines on thromboprophylaxis in orthopedic surgery. This issue, pp 678,83. [source] Venous thromboembolism in malignant gliomasJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 2 2010E. O. JENKINS Summary., Malignant gliomas are associated with a very high risk of venous thromboembolism (VTE). While many clinical risk factors have previously been described in brain tumor patients, the risk of VTE associated with newer anti-angiogenic therapies such as bevacizumab in these patients remains unclear. When VTE occurs in this patient population, concern regarding the potential for intracranial hemorrhage complicates management decisions regarding anticoagulation, and these patients have a worse prognosis than their VTE-free counterparts. Risk stratification models identifying patients at high risk of developing VTE along with predictive plasma biomarkers may guide the selection of eligible patients for primary prevention with pharmacologic thromboprophylaxis. Recent studies exploring disordered coagulation, such as increased expression of tissue factor (TF), and tumorigenic molecular signaling may help to explain the increased risk of VTE in patients with malignant gliomas. [source] Partial factor IXa inhibition with TTP889 for prevention of venous thromboembolism: an exploratory studyJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 3 2008B. I. ERIKSSON Summary.,Background:,Inhibitors of factor (F) IXa show potent antithrombotic activity with a low risk of bleeding in preclinical models. We investigated the anticoagulant potential of oral TTP889, a small molecule that inhibits up to 90% of FIXa activity at therapeutic doses, using a clinical model of extended prophylaxis in hip fracture surgery (HFS). Methods:,In this multicenter, randomized, double-blind study, 261 patients received oral TTP889 (300 mg once daily) or placebo starting 6,10 days after HFS, and standard thromboprophylaxis for 5,9 days. Treatment was continued for 3 weeks and all patients then underwent mandatory bilateral venography. The primary efficacy outcome was venous thromboembolism (VTE; venographic or symptomatic deep vein thrombosis or pulmonary embolism) during treatment, and it was evaluated centrally by an independent adjudication panel. The main safety outcome was bleeding (major, clinically relevant non-major, and minor events). Results:,Two hundred and twelve patients with an evaluable venogram were included in the efficacy analysis. The primary efficacy outcome occurred in 32.1% (35/109) of patients who had been allocated TTP889, and 28.2% (29/103) of patients on placebo (P = 0.58). There were no major bleeding events, and only two clinically relevant non-major bleeding events with TTP889. Conclusion:,Partial FIXa inhibition with TTP889 300 mg daily was not effective for extended prevention of VTE after standard prophylaxis for up to 9 days. Coupled with the low incidence of bleeding episodes, this suggests a lack of antithrombotic potential. Further investigation of TTP889 in different clinical settings is needed. (Clinical trial registration information URL: http://www.clinicaltrials.gov. Unique identifier: NCT00119457) . [source] Thromboprophylaxis rates in US medical centers: success or failure?JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 8 2007A. AMIN Summary.,Background:,As hospitalized medical patients may be at risk of venous thromboembolism (VTE), evidence-based guidelines are available to help physicians assess patients' risk for VTE, and to recommend prophylaxis options. The rate of appropriate thromboprophylaxis use in at-risk medical inpatients was assessed in accordance with the 6th American College of Chest Physicians (ACCP) guidelines.Methods:,Hospital discharge information from the Premier PerspectiveÔ inpatient data base from January 2002 to September 2005 was used. Included patients were 40 years old or more, with a length of hospital stay of 6 days or more, and had no contraindications for anticoagulation. The appropriateness of VTE thromboprophylaxis was determined in seven groups with acute medical conditions by comparing the daily thromboprophylaxis usage, including type of thromboprophylaxis, dosage of anticoagulant and duration of thromboprophylaxis, with the ACCP recommendations.Results:,A total of 196 104 discharges from 227 hospitals met the inclusion criteria. The overall VTE thromboprophylaxis rate was 61.8%, although the appropriate thromboprophylaxis rate was only 33.9%. Of the 66.1% discharged patients who did not receive appropriate thromboprophylaxis, 38.4% received no prophylaxis, 4.7% received mechanical prophylaxis only, 6.3% received an inappropriate dosage, and 16.7% received an inappropriate prophylaxis duration based on ACCP recommendations.Conclusions:,This study highlights the low rates of appropriate thromboprophylaxis in US acute-care hospitals, with two-thirds of discharged patients not receiving prophylaxis in accordance with the 6th ACCP guidelines. More effort is required to improve the use of appropriate thromboprophylaxis in accordance with the ACCP recommendations. [source] A dose escalation study of YM150, an oral direct factor Xa inhibitor, in the prevention of venous thromboembolism in elective primary hip replacement surgeryJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 8 2007B. I. ERIKSSON Summary.,Background:,YM150, a new oral direct factor Xa inhibitor is used as prophylaxis for venous thromboembolism (VTE), a well-known risk after orthopaedic surgery. Objectives:,To assess the safety and efficacy of thromboprophylaxis with YM150 in a dose escalation study. Patients/methods:,Patients (174) undergoing hip replacement surgery were randomized per cohort to oral once daily YM150 or subcutaneous enoxaparin (40 mg daily) in a 4:1 ratio for 7,10 days treatment. The YM150 doses were 3, 10, 30 and 60 mg by sequential four-dose escalation cohorts. The primary endpoint was major and/or clinically relevant non-major bleeding. The incidence of VTE was defined as a composite of verified symptomatic events and/or positive findings at bilateral venography on the last treatment day. An independent adjudication committee evaluated blindly the outcomes of the open-label study. Results:,No major and three clinically relevant non-major bleeds were reported, 1 (2.9%; 95% CI, 0.1,15.1) in the 3 mg and 2 (5.7%; 95% CI, 1.0,18.8) in the 10 mg YM150 dose groups. Of 147 patients (84%) with an evaluable venogram, VTE was observed in 51.9% (95% CI, 31.9,71.4), 38.7% (95% CI, 22.6,57.0), 22.6% (95% CI, 9.7,39.4), and 18.5% (95% CI, 7.5,36.5) in the YM150 dose groups 3, 10, 30 and 60 mg, respectively. A significant YM150 dose-related trend in VTE incidence was found (P=0.006). VTE with enoxaparin was 38.7% (95% CI, 22.6,57.0). Conclusions:,YM150, 10,60 mg daily, starting 6,10 h after primary hip replacement, was shown to be safe, well tolerated and effective. [source] Incidence of venous thromboembolism following major abdominal surgery: a multi-center, prospective epidemiological study in JapanJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 3 2006M. SAKON Summary.,Background:,Venous thromboembolism (VTE) has been considered to be a rare surgical complication in Japan. Aim:,To investigate the incidence and risk factors of VTE in Japanese patients undergoing major abdominal surgery. Methods:,A prospective, multi-center epidemiological study was conducted from December, 2001 to August 2002 in 39 medical institutes throughout Japan. A total of 173 patients with general (n = 128), gynecologic (n = 23), and urologic (n = 22) surgery were analyzed. For the diagnosis of deep vein thrombosis (DVT), bilateral venography was performed in all patients. Lung ventilation/perfusion scintigraphy was carried out in patients suspected of pulmonary thromboembolism (PTE). Results:,There were 36 patients with distal DVT (20.8%) and five patients with proximal DVT (2.9%). One patient was diagnosed as PTE. Overall, VTE was diagnosed in 42 patients (24.3%). By univariate analysis, only age (60 years or older) was identified as a significant risk factor in the whole study population. When analyzed by the stepwise multiple logistic regression model, female gender, operation site, age, and operation time were four risk factors found to be significant. The incidence of VTE was closely related to the number of risk factors that patients had. As many as 44% of patients with three or four risk factors developed VTE while those with one or two risk factors showed about a 17% incidence of VTE. Four patients lacking any risk factors did not develop VTE. Conclusions:,Venous thromboembolism is common in Japanese patients undergoing major abdominal surgery. Pharmacologic thromboprophylaxis is considered essential, particularly in those patients with multiple, potential risk factors. [source] Prevention of venous thromboembolism after acute ischemic strokeJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 6 2005P. W. KAMPHUISEN Summary., Venous thromboembolism (VTE) is a common complication after acute ischemic stroke. When screened by 125I fibrinogen scanning or venography, the incidence of deep-vein thrombosis (DVT) in stroke patients is comparable with that seen in patients undergoing hip or knee replacement. Most stroke patients have multiple risk factors for VTE, like advanced age, low Barthel Index severity score or hemiplegia. As pulmonary embolism is a major cause of death after acute stroke, the prevention of this complication is of crucial importance. Prospective trials have shown that both unfractionated heparin (UFH) and low molecular weight heparin (LMWH) are effective in reducing DVT and pulmonary embolism in stroke patients. Current guidelines recommend the use of these agents in stroke patients with risk factors for VTE. Some clinicians are concerned that the rate of intracranial bleeding associated with thromboprophylaxis may outweigh the benefit of prevention of VTE. Low-dose LMWH and UFH seem, however, safe in stroke patients. Higher doses clearly increase the risk of cerebral bleeding and should be avoided for prophylactic use. Both aspirin and mechanical prophylaxis are suboptimal to prevent VTE. Graduated compression stockings should be reserved to patients with a clear contraindication to antithrombotic agents. [source] Effect of age on the incidence of venous thromboembolism after major surgeryJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 8 2004R. H. White Summary.,Background:,Most guidelines for administration of thromboprophylaxis after major surgery use age as a major predictor of postoperative venous thromboembolism (VTE). We sought to quantify the effect of age on the risk of symptomatic VTE after a spectrum of surgical procedures. Methods:,Using the California Patient Discharge Data Set and specific ICD-9-CM surgical procedure codes, we retrospectively determined the incidence of VTE diagnosed within 91 days after 40 different urgent or elective surgeries performed in the hospital between 1992 and 1996. Logistic regression was used to quantify the effect of age on the incidence of postoperative VTE and to adjust for other risk factors. Results:,1 464 452 cases underwent one of 40 different procedures (mean cases per procedure = 35 718, range 4500,145 500). There was a significant interaction between age and the type of surgery performed (P<0.0001). Qualitative analysis of the effect of age on the incidence of VTE stratified by the presence or absence of malignancy revealed three general patterns: a steady increase in the incidence of VTE with age, exemplified by appendectomy or cholecystectomy; an increase in VTE up to approximately age 65 with no increase thereafter, exemplified by total hip arthroplasty; and no effect of age on the incidence of VTE, exemplified by vascular surgery. Conclusions:,The relationship between age and the risk of VTE after surgery is complex and depends on the nature of the surgery and the underlying pathologic process. Advancing age was a significant predictor for VTE following surgeries performed for conditions not inherently associated with significant comorbidity. Conversely, advancing age was not associated with a higher incidence of VTE after surgeries performed for conditions strongly associated with serious underlying comorbidity, such as a malignancy or severe peripheral vascular disease. [source] Post-thrombotic syndrome after central venous catheter removal in childhood cancer survivors is associated with a history of obstruction,PEDIATRIC BLOOD & CANCER, Issue 1 2010Shoshana Revel-Vilk MD Abstract Background A potential long-term complication of central venous catheter (CVC)-related deep vein thrombosis (DVT), both symptomatic and asymptomatic, is development of post-thrombotic syndrome (PTS) characterized by persistent pain, swelling, and skin changes. Signs and symptoms of PTS were reported after CVC removal. The aim of this study was to assess the risk factors for development of PTS in childhood cancer survivors. Procedure Children followed at the after cancer follow-up clinic were enrolled. The patients were screened for PTS using Kuhle's PTS pediatric score. Patient's records were retrospectively reviewed for clinical and CVC-related data. Results Fifty-one children were enrolled at a median of 2.3 (range 0.33,7.5) years after removal of their CVC. The median age of the children the time of treatment was 6.5 (range 0.25,18) years. Mild PTS was present in 20 children (39%, 95% CI 26,54%). Pain symptoms were reported in five children (9.5%, 95% CI 3.3,21.4%). Higher rate of PTS was found in children with history of CVC occlusion. The odd ratio (95% CI) for PTS in children with history of occlusion was 3.7 (95% CI 1.1,12.5%) (P,=,0.029). The occurrence of PTS was not associated with age at the time of treatment, time from CVC removal, duration of CVC, and history of infection. Conclusions Screening cancer survivors for PTS after CVC removal should be integrated to the after cancer follow-up clinic. Obstruction of CVC may indicate for asymptomatic DVT. Whether thromboprophylaxis and/or prevention of CVC occlusion can decrease the rate of PTS needs to be studied. Pediatr Blood Cancer 2010;55:153,156. © 2010 Wiley-Liss, Inc. [source] New agents for orthopaedic thromboprophylaxis: caution essential, but time will tellANZ JOURNAL OF SURGERY, Issue 11 2009Abhishek K. Verma BSc (Med), MB BS No abstract is available for this article. [source] Thromboprophylaxis practice patterns in hip fracture surgery patients: experience in Perth, Western AustraliaANZ JOURNAL OF SURGERY, Issue 10 2003Susan Wan Background: International guidelines recommend that all patients undergoing hip fracture surgery receive specific thromboprophylaxis. The purpose of the present study was to examine current thromboprophylaxis practice patterns in patients undergoing hip fracture surgery at Royal Perth Hospital. Methods: A total of 129 consecutive patients admitted to Royal Perth Hospital between 4 February and 21 July 2002 for surgical repair of a fractured neck of femur, was studied. The primary outcome was the frequency, type, and duration of thromboprophylaxis use during hospitalization. Results: Mean patient age was 79.4 ± 13.4 years and 69.8% (90/129) were female. Seventy-four patients (57.8%; 95% confidence interval (CI): 48.8,66.8%) received specific thromboprophylaxis during hospitalization, including 50 patients (39.1%; 95%CI: 30.6,48.1%) who received pharmacological prophylaxis only, three (2.3%; 95%CI: 0.5,6.7%) who received mechanical prophylaxis only, and 21 (16.4%; 95%CI: 10.5,24.0%) who received both mechanical and pharmacological prophylaxis. Of those receiving pharmacological prophylaxis, 35 (49.3%; 95%CI: 37.2,61.4%) received low-molecular-weight heparin, 26 (36.6%; 95%CI: 25.5,48.9%) received low-dose unfractionated heparin, eight (11.3%; 95%CI: 5.0,21.0%) received warfarin, 35 (49.3%; 95%CI: 37.2,61.8%) received aspirin or clopidogrel, and 27 (38.0%; 95% CI: 26.8,50.3%) received combined anticoagulant and antiplatelet prophylaxis. The median duration of mechanical prophylaxis was 8 days (range: 6,12 days) and that of pharmacological prophylaxis was 12 days (range: 6,26 days). When the 32 patients already taking aspirin or warfarin at the time of admission were excluded, only 45 (46.9%; 95%CI: 36.6,57.3%) of the remaining 96 patients received specific thromboprophylaxis. Conclusion: Specific thromboprophylaxis remains under-utilized in patients undergoing surgery for hip fracture at Royal Perth Hospital. These data should prompt the implementation of effective strategies to improve thromboprophylaxis practice patterns in high-risk orthopaedic patients. [source] Guidelines for the management of hypertensive disorders of pregnancy 2008AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 3 2009Sandra A. LOWE This is the Executive Summary of updated guidelines developed by the Society of Obstetric Medicine of Australia and New Zealand for the management of hypertensive diseases of pregnancy. They address a number of challenging areas including the definition of severe hypertension, the use of automated blood pressure monitors, the definition of non-proteinuric pre-eclampsia and measuring proteinuria. Controversial management issues are addressed such as the treatment of severe hypertension and other significant manifestations of pre-eclampsia, the role of expectant management in pre-eclampsia remote from term, thromboprophylaxis, appropriate fluid therapy, the role of prophylactic magnesium sulfate and anaesthetic issues for women with pre-eclampsia. The guidelines stress the need for experienced team management for women with pre-eclampsia and mandatory hospital protocols for treatment of hypertension and eclampsia. New areas addressed in the guidelines include recommended protocols for maternal and fetal investigation of women with hypertension, preconception management for women at risk of pre-eclampsia, auditing outcomes in women with hypertensive diseases of pregnancy and long-term screening for women with previous pre-eclampsia. [source] Antenatal pulmonary embolism: risk factors, management and outcomesBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 4 2008M Knight Objectives, To estimate the incidence of antenatal pulmonary embolism and describe the risk factors, management and outcomes. Design, A national matched case,control study using the UK Obstetric Surveillance System (UKOSS). Setting, All hospitals with consultant-led maternity units in the UK. Participants, A total of 143 women who had an antenatal pulmonary embolism between February 2005 and August 2006. Two hundred and fifty nine matched control women. Methods, Prospective case and control identification through the UKOSS monthly mailing. Main outcome measures, Incidence and case fatality rates with 95% CIs. Adjusted odds ratio estimates. Results, One hundred per cent of UK consultant-led obstetric units contributed data to UKOSS. A total of 143 antenatal pulmonary embolisms were reported, representing an estimated incidence of 1.3 per 10 000 maternities (95% CI 1.1,1.5). Seventy per cent of women had identifiable classical risk factors for thromboembolic disease. The main risk factors for pulmonary embolism were multiparity (adjusted odds ratio [aOR] 4.03, 95% CI 1.60,9.84) and body mass index , 30 kg/m2 (aOR 2.65, 95% CI 1.09,6.45). Nine women who had a pulmonary embolism should have received antenatal thromboprophylaxis with low-molecular-weight heparin (LMWH) according to national guidelines; only three (33%) of them did. Six women (4%) had a pulmonary embolism following antenatal prophylaxis with LMWH; three of these women (50%) were receiving lower than recommended doses. Two women had recurrent pulmonary emboli (1.4%, 95% CI 0.2,5.1%). Five women died (case fatality 3.5%, 95% CI 1.1,8.0%). Conclusions, Significant severe morbidity from thromboembolic disease underlies the maternal deaths from pulmonary embolism in the UK. This study has shown some cases where thromboprophylaxis was not provided according to national guidelines, and there may be scope for further work on guideline implementation. [source] The effect of graduated compression stockings on blood velocity in the deep venous system of the lower limb in the postnatal periodBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 10 2007R Jamieson Venous thromboembolism (VTE) is the leading cause of maternal mortality in the UK and is also a major cause of long-term morbidity. Recent UK national guidelines recommend thromboprophylaxis, which includes the use of graduated compression stockings (GCS), for high-risk women to reduce the risk of VTE in both the antenatal and postpartum period. This study of 17 women examined the effects of GCS on the deep venous system in the immediate postpartum period and found a statistically significant reduction in the diameter of the common femoral vein (CFV) (pre- versus post stocking diameter: mean 10.39 mm [SD 2.09] versus mean 9.69 mm [SD 1.99]) and an increase in the rate of blood velocity in the CFV (pre- versus post stocking velocity: mean 10.0 cm/s [SD 2.7] versus 13.9 cm/s [SD 4.2]) 30 minutes after application of thigh length GCS in women 1 or 2 days following a singleton vaginal delivery at term. This confirms reduction in venous stasis in the deep venous system in the immediate postpartum woman by the use of GCS, supporting their use in improving venous function in this context. [source] Antenatal use of enoxaparin for prevention and treatment of thromboembolism in pregnancyBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 9 2000Joanne Ellison Clinical Research Fellow Objective To assess the safety and efficacy of enoxaparin use for thromboprophylaxis or treatment of venous thromboembolism during pregnancy. Design Retrospective review of casenotes of women who received enoxaparin during pregnancy. Setting Obstetric Medicine Unit at Glasgow Royal Maternity Hospital. Sample Data were obtained on 57 pregnancies in 50 women over six years. Methods Information was obtained from case records in relation to outcome measures, the presence of underlying thrombophilia and indication for anticoagulation. Main outcome measures Incidences of venous thromboembolism, haemorrhage, thrombocytopenia, peak plasma anti-factor Xa levels and symptomatic osteoporosis. Results There were no thromboembolic events in the thromboprophylaxis group. There were no incidences of heparin-induced thrombocytopenia. Twenty-two women had spinal or epidural anaesthesia and no complications were encountered. There was one instance of antepartum haemorrhage following attempted amniotomy in a woman with previously unknown vasa praevia. Two women sustained postpartum haemorrhage, both secondary to vaginal lacerations, resulting in blood loss > 1000 mL. Blood loss following caesarean section was not excessive. No instances of vertebral or hip fracture were encountered. The median peak plasma anti-factor Xa level on a dose of 40 mg once daily was 0.235 U/mL; peak plasma anti-factor Xa levels were not affected by gestational age. Conclusions The use of enoxaparin in pregnancy is associated with a low incidence of complications and a dose of 40 mg once daily throughout pregnancy provides satisfactory anti-factor Xa levels and appears effective in preventing venous thromboembolism. [source] A risk score for the management of pregnant women with increased risk of venous thromboembolism: a multicentre prospective studyBRITISH JOURNAL OF HAEMATOLOGY, Issue 6 2009Yesim Dargaud Summary Patients with thrombophilia and/or a history of venous thromboembolism (VTE) exhibit a high risk of thrombosis during pregnancy. The present multicentre study prospectively assessed a prophylaxis strategy, based on a risk score, in pregnancies with increased risk of VTE. Among 286 patients included in the study, 183 had a personal history of VTE (63·98%) and 191 patients (66·8%) had a thrombophilia marker. Eighty nine (46·6%) thrombophilic women had a personal history of VTE. Patients were assigned to one of three prophylaxis strategies according to the risk scoring system. In postpartum, all patients received low molecular weight heparin (LMWH) prophylaxis for at least 6 weeks. In antepartum, LMWH prophylaxis was prescribed to 61·8% of patients with high risk of VTE. Among them, 37·7% were treated in the third trimester only and 24·1% were treated throughout pregnancy. In this cohort, one antepartum-related VTE (0·35%) and two postpartum-related VTE (0·7%) occurred. No case of pulmonary embolism was observed during the study period. The rate of serious bleeding was 0·35%. There was no evidence of heparin-induced thrombocytopenia or osteoporosis. The use of a risk score may provide a rational decision process to implement safe and effective antepartum thromboprophylaxis in pregnant women at high risk of VTE. [source] | ||||||||||||||||||||||||||||